NCT05311748

Brief Summary

Background: The aim of this study is to evaluate the usefulness of Power Doppler in order to improve the diagnostic work up of veno-occlusive erectile dysfunction patients. Materials and Methods: Two hundred and two patients affected by erectile dysfunction, mean IIEF 5 = 13.5 (12-17) for at least 6 months, were enrolled in a prospective cross-sectional study. All patients underwent Dynamic Power Doppler after intracevernous injection of vasoactive drugs. Poor responders patients subsequently underwent to cavernosometry to get a full assessment of the vascular framework.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
202

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2014

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2014

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 13, 2017

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2019

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

March 15, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 5, 2022

Completed
Last Updated

April 5, 2022

Status Verified

March 1, 2022

Enrollment Period

3.2 years

First QC Date

March 15, 2022

Last Update Submit

March 25, 2022

Conditions

Erectile Dysfunction Due to Arterial Disease

Outcome Measures

Primary Outcomes (1)

  • Echocolour doppler Evaluation of the Index of Maintenance of Erection (n.v. <0.25).

    Every subject will be studied by penile ultrasound with color doppler

    90 days

Interventions

Ultrasound and dopplerDIAGNOSTIC_TEST

Penile echocolour doppler ultrasound

Eligibility Criteria

Age18 Years - 75 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Male patients affected by erectile dysfunction for at least 6 months

You may qualify if:

  • Erectile dysfunction

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Urology Unit, Sapienza University of Rome

Latina, 04100, Italy

Location

Alessandro Zucchi

Pisa, Italy

Location

Related Publications (1)

  • Kim N, Azadzoi KM, Goldstein I, Saenz de Tejada I. A nitric oxide-like factor mediates nonadrenergic-noncholinergic neurogenic relaxation of penile corpus cavernosum smooth muscle. J Clin Invest. 1991 Jul;88(1):112-8. doi: 10.1172/JCI115266.

    PMID: 1647413RESULT

MeSH Terms

Interventions

Ultrasonography, Doppler

Intervention Hierarchy (Ancestors)

UltrasonographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PROF, MD, PhD

Study Record Dates

First Submitted

March 15, 2022

First Posted

April 5, 2022

Study Start

January 15, 2014

Primary Completion

March 13, 2017

Study Completion

July 15, 2019

Last Updated

April 5, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

IT(2)